Quality and Compliance

Quality management and new product introduction, including technology transfer and industrialisation in Europe and the US; QP services.

PDS provides an interim management service for QA, either as a temporary replacement for a member of staff, or for emergent companies intending to establish a European office. A management service can also be provided for a particular project, such as the development of a new documentation system.

Experience

PDS staff possess over 20 years of experience at senior levels in quality management and new product introduction, including technology transfer and industrialisation in Europe and the US. Members of PDS staff are eligible for nomination under the permanent provisions of EU Directives 2001/83/EC and 2001/20/EC. PDS has proven experience with contractor evaluation and selection, conventional pharmaceutical products, biotechnology and devices. Other projects have included the management of cross-functional teams to transfer global products from R&D to commercial supply.

Quality strategy

PDS advises on quality strategy for new products in the EU and US, and can provide development and packaging strategies to optimise the characteristics of the product. This is in terms of formulation, presentation, packaging and manufacturing economics.

Quality management systems

PDS can develop new quality management systems, specified to the structure and operation of the client. This is aligned with the needs of GMP, ISO 9000 and other relevant quality systems concepts.

Contractor management

PDS carries out routine contractor GMP reviews and in-depth audits for specific projects covering facilities, quality systems, manufacturing, packaging and analytical operations. This is both for small molecules and for biotechnology products.

Regulatory inspections

PDS assists companies to gain regulatory approval by reviewing the manufacturing processes and the submitted data, GMP review of the manufacturing facilities and quality management systems. PDS works with in-house QA experts to optimise the presentation of the facility and systems to the investigator, prepares response documents or appeals, and appears at oral hearings on behalf of the applicant.

Qualified person

PDS can provide a contract QP service to companies manufacturing or supplying both commercial and investigational medicinal products. Regulatory, manufacturing, packaging and labelling advice for clinical trial supplies can also be provided.